Financial conflict of interest for members on breast implant advisory panel
unacceptable

Public hearings to be held next week

Three members of the advisory panel appointed by Health Canada to review
the possible re-approval of silicone breast implants for the Canadian
market have ties to the manufacturers, and the government does not
appear to have any intention of removing them before the public hearings
taking place September 29, 2005.

"This is an unacceptable conflict of interest that questions the
legitimacy of the whole process," says Prof. Abby Lippman of McGill
University and member of Women and Health Protection, a working group
that monitors the regulatory activities of Health Canada for their
impact on women's health. "What is the point of collecting information
about conflict of interest and then doing absolutely nothing about it?"
she adds.

Applications have been submitted to Health Canada by Inamed and Mentor
for the reintroduction of silicone breast implants, and are currently
under review. Health Canada has asked the panel to advise the House of
Commons Standing Committee on Health about the safety and efficacy
profile of the products based on scientific, medical and clinical
evidence. However, the panel was also asked to declare any conflicts of
interest prior to their participation on the panel. According to the
Canadian Medical Association Journal, three panel members admitted to
receiving funds directly from the manufacturers whose products are under
review.

Dr. Harold Brandon from Washington University in St. Louis Missouri and
Dr. Michael Brook from McMaster University in Hamilton were paid by
Inamed to provide information to FDA advisory panel members supporting
Inamed's application for approval to sell the same style of silicone gel
breast implants at the FDA's meeting this past April. This was only one
month after their participation on a Health Canada secret panel meeting
on breast implants, and just five months before being appointed to the
current Health Canada panel to consider silicone gel breast implants.

Dr. Mitchell Brown of Sunnybrook and Women's College Health Sciences
Centre in Toronto has also received funding to take part in the
promotion of products made by the manufacturers of the silicone implants
under review. Advertising for his clinic that recently appeared in a
cosmetic surgery supplement in the Globe and Mail promotes the
wide-spread use of the unapproved silicone gel implants ( 09/14/05 ).
Also, a recent journal article of which Brown is the lead author states
that: "Cohesive gel implants are likely to play an important role in
aesthetic and reconstructive breast surgery when silicone gel implants
are reintroduced into the North American market" (Plast. Reconstr. Surg.
116: 768). It sounds as if Brown considers the approval process a
foregone conclusion. Could his bias be more clear?

"You would be hard pressed to find a more glaring, outrageous conflict
of interest other than having the CEOs and full-time scientists of
Inamed and Mentor on the panel," says Dr. Diana Zuckerman of the
Washington-based National Research Center for Women and Families. "What
are Health Canada officials thinking? There is absolutely no way to
justify their participation on the panel with a straight face."

Dr. Zuckerman was responsible for the US Congressional investigation of
the lack of safety data on breast implants in the early 1990s, and
testified at the FDA panel meetings on silicone gel breast implants in
2003 and in April 2005. In the spring of this year, she met with
officials at Health Canada to discuss the need for a transparent process
in Canada that made room for consumer and expert input. She was taken
aback to read that three industry-sponsored consultants were appointed
to the panel. "It flies in the face of everything we know about having
objective scientific review," adds Zuckerman.

Canada repeating mistakes of FDA

The announcement that the consultants who were paid by the industry to present
at the FDA hearings will also be sitting on what is
supposed to be an independent advisory panel for Health Canada at the
end of September is cause for concern to Joyce Attis, a founding member
of the Breast Implant Line of Canada, a support group for women who have
had breast implants.

"The Senate in the US is probing the Breast Implant Advisory Panel
conflict of interest. Kudos to them for following through on this
important issue. Will our government follow suit and address the fact
that there are three members of the breast implant advisory committee
who were paid as consultants by the very two applicants attempting to
get their silicone gel breast implants back onto the Canadian market?
Something smells here. Let's clean up the stench!"

Continued safety concerns with silicone implants
Silicone breast implants were withdrawn from the Canadian market in 1992
after serious safety concerns were raised. A series of successful
lawsuits against the manufacturer followed. The move by Inamed and
Mentor to reintroduce an ostensibly improved model of the silicone gel
breast implant on the Canadian market has many health and women's
organizations very concerned.

"Silicone gel breast implants have greater risks than saline implants,
with no long-term safety data available from either company submitting
its application to Health Canada ," says Anne Rochon Ford, Coordinator of
Women and Health Protection. "This is problematic as the more serious
health concerns with these implants - mostly related to rupture -- tend
not to show up right away."

A study of silicone implants conducted by FDA scientists in 2000
reported a failure rate of 55% per implant in women who had breast
implants for augmentation for an average of 16 years. Other studies
show much higher rates of rupture, pain, and other complications among
breast cancer patients using implants after a mastectomy. "More and
more women receiving implants at a young age may anticipate multiple
surgeries with added financial burdens," says Ford. "Teenaged
girls are receiving them as birthday and graduation presents from their parents,"
adds Ford. "Does Health Canada really want to be condoning such
misguided promotion of a distorted body image amongst young women and
girls, especially with a product with such a dubious track record?"

Research conducted at the British Columbia Centre of Excellence for
Women's Health (BCCEWH) also documented the growing costs to provinces
as more women develop complications from breast implant surgery, and
return continuously to the health care system for additional surgeries
and other interventions and treatment related to implant rupture.
"Would any other medical device that failed in more than half the people
in which it was used and that itself created so many significant
problems ever be approved?" asks Lippman.

Public consultation process also flawed
Health Canada has invited the general public to take part in the review
of silicone breast implant applications by asking individuals and
organizations to register to present their viewpoints and evidence to
the Health Canada appointed expert review panel, or by commenting in an
online forum.

However, in order to adequately comment on the applications, the public
needs to see the industry data on silicone implants, which was not made
available to the public on Health Canada 's website until September 13,
2005 . Registration for public participation was originally due
September 9, and then extended to September 16, leaving only 3 days for
organizations and individuals to review the data and register.

"The government has made a multitude of claims about a commitment to
transparency in the drug and devices regulation process," says Ford.
"Transparency must include information about the products in time for
people to make substantive comments. This is a violation of public
trust."